Skip to main content
OpenTrials
Completed

NCT Number: NCT03103243

Pilot Study to Investigate Contemplative Intervention in Lupus Patients

The study tests whether contemplative-based intervention can modify pathogenic processes in participants with Lupus. Techniques such as meditation, mindfulness and yoga may have an impact on the disease and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Additionally, incorporating patients' caregivers may strengthen their relationships and, thereby, improve their health and well-being.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Virginia

Charlottesville, Virginia, 22903, United States

About this study

The objective of this pilot study is to test the feasibility of an innovative contemplative-based and caregiver-inclusive intervention can modify pathogenic processes in systemic lupus erythematosus (SLE). Contemplative techniques such as meditation, mindfulness and yoga may have an impact on the disease burden and may decrease psychological distress, increase self-regulation capabilities, and reduce pain. Research also suggests that contemplative practices, such as an intensive mindfulness intervention, may have a direct effect on the underlying disease process itself by altering epigenetic control of gene expression, decreasing proinflammatory cytokine production and reestablishing immunologic homeostasis. It is also well documented that social relationships moderate physical health. Incorporating patients' caregivers may strengthen their relationships and thereby improve their health and well-being. It is anticipated that the successful outcome of the intervention described in this proposal will provide the basis for a new and effective contemplative-based and caregiver-inclusive therapy for SLE and other rheumatic diseases.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Males and females who have given written informed consent
  • 18 and older
  • Literate in English: able to read, understand, follow instructions, and complete the rating scales and questionnaires accurately
  • Have a clinical diagnosis of systemic lupus erythematosus
  • Must pass the initial MRI screening administered over the phone
  • Inclusion criteria for support person: must be able to attend sessions with SLE patient.

Exclusion criteria

  • Significant previous mindfulness training and experience (e.g. MBSR course, daily meditation practice)
  • Any current Axis I DSM-IV-TR psychiatric disorder that, in the clinician's opinion, warrants treatment or would preclude safe participation in the protocol, including, but not limited to: psychosis, schizophrenia, dementia, schizotypal personality disorder, borderline personality disorder, bipolar disorder, primary diagnosis of eating disorder, or chronic suicidality or homicidality.
  • Have clinical evidence of significant unstable or uncontrolled acute or chronic diseases not related to SLE (i.e., diabetes, cardiovascular, pulmonary, hematologic, gastrointestinal, neurological, or infectious) which, in the opinion of the treating physician, could confound the results of the study or put the patients at undue risk
  • Chronic use of prescribed or recreational psychoactive drugs (self-reported)
  • Have current drug or alcohol abuse or dependence, or a history of drug or alcohol abuse or dependence within 364 days prior to Baseline (self-reported)
  • Diagnosis of lupus for over 20 years
  • Too sick to meaningfully participate (e.g. hospitalized, flaring at the time of screening)
  • In order to participate in the MRI portion of the study, participants must pass the in-person MRI screening administered by the MRI technician before each MRI. If participants fail the in-person MRI screening, they will be excluded from the MRI portion of the study, but can still participate in the intervention and blood draw portions of the study.

Treatment and study plan

Mindfulness Based Group Sessions

Behavioral

In-person group intervention sessions conducted with a combination of meditation, group exercise (yoga), group discussions, deep breathing and other mindfulness based practices.

Primary outcomes

  1. Change from baseline in blood

    Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention

    Number of participants with abnormal lab values (Complete Blood Count, Chemistry Panel, Autoantibodies, Complement C3 & C4, Cytokines)

Secondary outcomes

  1. Change from baseline in brain activity during functional MRI

    Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention

    Number of participants with change in brain activity during functional MRI tasks (Handholding, Balloon Analog Risk Task, Penn Emotion Recognition Task, Operation Span Task, Resting State Task)

  2. Change from baseline in Patient Reported Outcomes

    Time frame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention

    Patient-reported change in health and symptoms

  3. Change from baseline in SLE disease activity

    Time frame: Baseline Assessment, within 2 weeks prior to intervention, within 2 weeks after intervention

    Systemic Lupus Activity Questionnaire (SLAQ)

  4. Change from baseline in psychosocial function

    Time frame: Baseline Assessment, within 2 weeks prior to intervention, throughout the 6-week intervention, within 2 weeks after intervention

    Self reported psychosocial function

  5. Change from baseline in Heart Rate Variability

    Time frame: Throughout the entire 6-week intervention

    Collected using emWave device

Sponsors and collaborators

Lead sponsor

University of Virginia

Other

Collaborators

  • Lupus Research Alliance

Registry information

Official study title

A Pilot Study to Investigate a Contemplation-Based Intervention and Health Outcomes in Systemic Lupus Erythematosus Patients

Acronym: LUPP

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Apr 6, 2017
Registry last updated
Mar 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.